Trial Outcomes & Findings for Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke (NCT NCT02322411)

Results Overview

Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

After 8 weeks and 12 weeks

Results posted on

2020-07-15

Participant Flow

30 participants were consented to the study, 14 randomized to the compensatory arm, 16 to the I-PRO + compensatory arm. 1 participant in the compensatory arm withdrew after baseline residue analysis only (this participant's data is reported at baseline in the Residue Analysis Outcome Measure)

Participant milestones

Participant milestones
Measure	Compensatory This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Overall Study STARTED	14	16
Overall Study Randomized	14	16
Overall Study All Baseline Measures Analyzed	13	16
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Compensatory This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Overall Study Lost to Follow-up	4	7
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effects of Oropharyngeal Strengthening on Dysphagia in Patients Post-stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches	Total n=29 Participants Total of all reporting groups
Age, Continuous	73.4 years STANDARD_DEVIATION 15.5 • n=5 Participants	68.9 years STANDARD_DEVIATION 12.0 • n=7 Participants	70.9 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 8 weeks and 12 weeks

Population: Front/Back Lingual Pressure at 8 weeks and 12 weeks - 6 subjects for Compensatory group Front/Back Lingual Pressure at 8 weeks - 8 subjects for I-PRO group Front/Back Lingual Pressure at 12 weeks - 6 subjects for I-PRO group

Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device

Outcome measures

Outcome measures
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) Front Lingual Pressure at 8 weeks	83.3 hPa Standard Deviation 71.9	239.6 hPa Standard Deviation 123.0
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) Front Lingual Pressure at 12 weeks	129.8 hPa Standard Deviation 108.0	386.3 hPa Standard Deviation 229.9
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) Back Lingual Pressure at 8 weeks	31.5 hPa Standard Deviation 52.6	127.6 hPa Standard Deviation 158.9
Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures) Back Lingual Pressure at 12 weeks	50.05 hPa Standard Deviation 55.6	131.4 hPa Standard Deviation 118.9

SECONDARY outcome

Timeframe: baseline, 8 and 12 weeks

Population: Not all participants had analyzable swallow studies, one participant in the Compensatory Arm withdrew from the study after the baseline residue analysis.

Measurement of Residue

Outcome measures

Outcome measures
Measure	Compensatory n=14 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=14 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Percent Residue Baseline Total Residue	9.12 Percent Residue Standard Deviation 8.39	10.20 Percent Residue Standard Deviation 8.54
Percent Residue 8-Week Total Residue	7.14 Percent Residue Standard Deviation 5.22	7.12 Percent Residue Standard Deviation 4.67
Percent Residue 12-Week Total Residue	5.65 Percent Residue Standard Deviation 3.27	7.55 Percent Residue Standard Deviation 4.27

SECONDARY outcome

Timeframe: After 8 and 12 weeks

Population: Data for this secondary outcome measure was not collected as the equipment stopped working at the start of the study. The study team did not have the resources to purchase new equipment to collect these data.

Pressures will be measured while the subject is swallowing during the videofluoroscopic swallow study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 8 weeks and 12 weeks

Population: SWAL-QOL score at 8 weeks - 9 subjects for I-PRO group SWAL-QOL score at 12 weeks - 6 subjects for I-PRO group SWAL-QOL score at 8 weeks - 7 subjects for compensatory group SWAL-QOL score at 12 weeks - 7 subjects for compensatory group

A quality of life questionnaire related to swallowing. The scores range from 0-100, and a higher score indicates a higher quality of life related to swallowing.

Outcome measures

Outcome measures
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Dysphagia-related Quality of Life Scores (SWAL-QOL) SWAL-QOL score at 8 weeks	86.0 score on a scale Standard Deviation 14.6	85.5 score on a scale Standard Deviation 8.5
Dysphagia-related Quality of Life Scores (SWAL-QOL) SWAL-QOL score at 12 weeks	88.9 score on a scale Standard Deviation 5.0	86.3 score on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: After 8 weeks and 12 weeks

Population: FOIS score at 8 weeks - 9 subjects for I-PRO group FOIS score at 8 weeks - 10 subjects for compensatory group FOIS score at 12 weeks - 8 subjects for I-PRO group FOIS score at 12 weeks - 6 subjects for compensatory group

FOIS scores reflect level of nutritional intake. Scores range from 1 to 7, with 1 being nothing by mouth and with 7 indicating a diet with no restrictions. Qualitative assessment via interview. Range of final scores is between 1 and 7. Average scores of each arm reported at 8 and 12 weeks.

Outcome measures

Outcome measures
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Functional Oral Intake Scale (FOIS) Scores FOIS score at 8 weeks	5.6 score on a scale Standard Deviation 1.9	6.8 score on a scale Standard Deviation 0.4
Functional Oral Intake Scale (FOIS) Scores FOIS score at 12 weeks	5.8 score on a scale Standard Deviation 1.2	6.9 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: up to 9 months

The number of pneumonia diagnoses within 9 months following completion of the program will be compared to the same pre-enrollment period.

Outcome measures

Outcome measures
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Pneumonia Diagnoses (Number of Pneumonia Diagnoses)	0 incidences of pneumonia	0 incidences of pneumonia

SECONDARY outcome

Timeframe: up to 9 months

The number of hospital admissions and readmissions within 9 months following completion of the program will be compared to the same pre-enrollment period.

Outcome measures

Outcome measures
Measure	Compensatory n=13 Participants This group will receive standard swallowing intervention, which is identified by the SLP as appropriate to treat the patient's dysphagia and is common clinical practice. Their therapy may include: 1) modifying their foods and fluids; 2) changing their posture when they eat or drink; or 3) having them eat more slowly or in a quiet environment to make swallowing easier and safer. These compensatory approaches will ensure safety while swallowing foods and fluids. Range of motion, vocal exercises, and other oromotor exercises, such as the Shaker Exercise, as well as any other potential strengthening regimens for swallowing or speech will be delayed until subjects have completed participation. Compensatory approaches	I-PRO + Compensatory n=16 Participants The Device-Facilitated Isometric Progressive Resistance Oropharyngeal (D-F I-PRO) intervention will be completed using the SwallowSTRONG® device. Tongue press exercises consist of pressing the tongue against the sensors located along the hard palate. Isometric exercises will focus on the anterior and posterior sensor. Subjects will take the SwallowStrong® device home with them and will complete 20 repetitions of the exercise (10 repetitions at the front sensor; 10 repetitions at the back sensor), three times per day on three days per week for twelve weeks. Isometric Progressive Resistance Oropharyngeal Therapy: Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device. Compensatory approaches
Hospital Admissions (Number of Hospital Admissions and Readmissions) Admissions pre-enrollment	1 hospital admissions	0 hospital admissions
Hospital Admissions (Number of Hospital Admissions and Readmissions) Admission post-enrollment	0 hospital admissions	0 hospital admissions

Adverse Events

Compensatory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

I-PRO + Compensatory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicole Pulia

University of Wisconsin - Madison

Phone: 6082561901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place